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Technical File Documentation
Let KD&A help you with the development of Technical File Documentation that complies with the medical device regulations
KD&A provides Technical File and Design Dossier development services for medical device and IVD manufacturers operating in Australia and global markets, supporting regulatory submissions and ongoing compliance across the full product lifecycle.
We help organisations compile complete and structured Technical Files that demonstrate conformity with applicable legislation, standards and common specifications, streamlining certification and market-access activities.
KD&A styles Technical Documentation to your device type, risk classification and target markets.
FAQ 1: What is a Technical File and why is it required?
A Technical File (sometimes called a Design Dossier) is the core set of documents regulators and notified bodies use to assess whether a medical device or IVD complies with applicable safety, performance and regulatory requirements. It typically includes design information, risk management, clinical evidence, labelling, manufacturing controls and post-market systems.
FAQ 2: Do you prepare Technical Files for multiple jurisdictions?
Yes. KD&A prepares Technical Documentation aligned to Australian, European and other global regulatory frameworks, including ARTG submissions and EU MDR conformity assessments.
Who this service is for
- Medical device manufacturers
- IVD developers
- Digital health / SaMD companies
- Start-ups preparing for certification
- Multinationals entering Australia
- Sponsors managing offshore manufacturers
We pride ourselves on providing excellent
customer service to our clients
Cyclomedica Australia Pty Ltd
In the 2.5 years we have been working together, no task or challenge is too small or too big. They take both extremes with enthusiasm and ownership not often seen with other consultants. In fact, we don’t see them as consultants, they are an integral part of our team.
CT Healthcare
We have found KD&A’s service, support and understanding invaluable in helping to guide our business through different situations that have arisen. Their work has been done in an extremely professional, efficient and prompt manner, which has been important in situations where immediate action has been needed.
SPD Development Company Ltd
In the 5 years we have been working together, we have found KD&A to be helpful, knowledgeable and always professional. Their ability to provide clear, accurate and timely responses to regulatory enquiries has been valuable to our business.
PainChek
We have found KD&A’s services to be solution driven, the team is professional and efficient. I highly recommend KD&A regulatory services and expertise.
Bodyflow International Pty Ltd
“KD&A provided Bodyflow with professional, informative and relevant regulatory advice. In addition, the workshop I attended (held by KD&A along with two other regulatory consultants) allowed for interactive learning – growing my understanding of the requirements for our medical device.”
Elastagen Pty Ltd
“KD&A have provided invaluable quality management system and regulatory support as Elastagen has successfully transitioned from an R&D organisation to a clinical stage medical device company operating in compliance with ISO 13485 & 21CFR820. KD&A have been by our side from day 1 and are always available to help with any of our regulatory questions.”
Opto Global Pty Ltd
“KD&A have been providing Opto global with high quality and professional assistance for 5 years. Their service is delivered efficiently, thoroughly and within the required timeframe.”
Signostics Ltd
“We have used KD&A’s services since our inception. Initially, KD&A managed the creation of our quality system, which they implemented quickly and efficiently. Since the initial engagement we have grown and employed quality and regulatory managers, with KD&A continuing to provide quality management and regulatory affairs advice. They have always been responsive and totally professional in their approach and dealings. We have no hesitation in recommending them.”
Australian Dental Manufacturing Pty Ltd
“We could not help but come away with respect for, and impressed with, the service KD&A provided to our company. I would not hesitate in recommending KDA to anyone who needs to deal with TGA regulatory requirements.”
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Kea Dent
Managing Director
Bibiana Franco
Senior Associate
Louise Pirauo
Senior Associate
Mya Imgraben
Associate
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